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真实世界环境下资源匮乏地区第三孕期高血压妊娠管理中门诊生物标志物的应用:ROBUST 研究。

Real life outpatient biomarker use in management of hypertensive pregnancies in third trimester in a low resource SeTting: ROBUST study.

机构信息

Department of Maternal Fetal Medicine, Mirror Health, Bengaluru, India.

Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of Chicago, IL, United States.

出版信息

Pregnancy Hypertens. 2021 Mar;23:97-103. doi: 10.1016/j.preghy.2020.11.010. Epub 2020 Dec 3.

Abstract

OBJECTIVES

The utility of angiogenic biomarkers in a low resource outpatient setting is not well known. This study evaluates the clinical utility of angiogenic biomarkers, soluble fms-like tyrosine kinase 1 (sFlt1) and placental growth factor (PlGF) among patients at risk for preeclampsia in a low resource outpatient setting.

STUDY DESIGN

This was a prospective pilot study among high risk third trimester outpatients conducted in Bengaluru, India. Serum sFlt1/PlGF was measured between 28 and 37 weeks. Patients with high risk ratio were managed with close observation, intermediate risk had serum redrawn in one week, and those with low risk ratio received routine care. Delivery decisions were made based on local protocols.

MAIN OUTCOME MEASURES

Maternal complication rate, development of preeclampsia with severe features, and latency to delivery was examined by sFlt1/PlGF ratio.

RESULTS

The study included 50 patients. Compared to women with a low risk ratio, women with a high-risk ratio were more likely to have preeclampsia with severe features (90.91% vs 8.00%, p < 0.0001), a higher composite maternal complication rate (18.18% vs 0%, p = 0.04) and deliver at earlier gestational ages (32.57 [30.43, 34.71] vs 37.43 [36.86, 38.14] weeks, p = 0.0001).

CONCLUSION

Angiogenic factors may have utility in the low resource outpatient setting for women with a hypertensive disease. Low sFlt1/PlGF levels were associated with a longer latency to delivery and no maternal complications. This study confirms the broad clinical utility of biomarkers in the real world.

摘要

目的

在资源有限的门诊环境中,血管生成生物标志物的实用性尚不清楚。本研究评估了血管生成生物标志物可溶性 fms 样酪氨酸激酶 1(sFlt1)和胎盘生长因子(PlGF)在资源有限的门诊环境中处于子痫前期风险的患者中的临床实用性。

研究设计

这是在印度班加罗尔进行的一项针对高危妊娠晚期门诊患者的前瞻性试点研究。在 28 至 37 周之间测量血清 sFlt1/PlGF。高危比值的患者接受密切观察,中危比值的患者在一周内重新采血,低危比值的患者接受常规护理。分娩决策基于当地协议做出。

主要观察结果

通过 sFlt1/PlGF 比值评估产妇并发症发生率、严重子痫前期的发生以及分娩潜伏期。

研究结果

该研究纳入了 50 名患者。与低风险比值的女性相比,高风险比值的女性更有可能发生严重特征的子痫前期(90.91% vs 8.00%,p<0.0001)、更高的复合产妇并发症发生率(18.18% vs 0%,p=0.04)和更早的分娩年龄(32.57[30.43,34.71] vs 37.43[36.86,38.14]周,p=0.0001)。

结论

血管生成因子在资源有限的门诊环境中对子痫前期患者可能具有实用性。低 sFlt1/PlGF 水平与分娩潜伏期延长和无产妇并发症相关。本研究证实了生物标志物在现实世界中的广泛临床实用性。

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